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FDA-RELATED NEWS
 
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TXT Janssen Files BLA for Myeloma Therapy
12/09/2022
 
 
TXT 2 Roche Alzheimer’s Tests Cleared by FDA
12/09/2022
 
 
TXT 10 Observations in Aurobindo Unit FDA-483
12/08/2022
 
 
TXT Non-Device Software Function Report
12/08/2022
 
 
TXT Draft VMSR Guidance for Manufacturers
12/08/2022
 
 
TXT 16 Observations on Lupin Unit FDA-483
12/08/2022
 
 
TXT FDA Proposes More Comprehensive IND Reports
12/08/2022
 
 
TXT Draft Device Human Factors Guidance
12/08/2022
 
 
TXT Comments on Pediatric Clinical Pharmacology Draft
12/08/2022
 
 
TXT FDA Manuscript in the Works on Trial Diversity Strategy
12/08/2022
 
 
TXT FDA Urges Oncopeptides to Withdraw Multiple Myeloma Drug
12/07/2022
 
 
TXT FDA Accelerated Approvals Down This Year: AP
12/07/2022
 
 
TXT FDA Denies Homeopathy Petition
12/07/2022
 
 
TXT Significant HCT/P Deviations at Cryos International
12/07/2022
 
 
TXT FDA Denies Petition on Scrubs as Medical Devices
12/07/2022
 
 
TXT PhRMA Issues with FDA Medical Queries
12/07/2022
 
 
TXT Device Shortages Need More Transparency: FDA
12/07/2022
 
 
TXT Coalition for Health AI Meeting Summary
12/07/2022
 
 
TXT FDA Defends Training/Support of Team Biologics
12/07/2022
 
 
TXT AG Hair Limited CGMP Issues
12/06/2022
 
 
TXT CGMP Violations at Glenmark Pharmaceuticals
12/06/2022
 
 
TXT CGMP Violations in Kari Gran Inspection
12/06/2022
 
 
TXT FDA Maintains ‘High Bar’ for P13K Inhibitors
12/06/2022
 
 
TXT FDA Developed New Covid Drug Surveillance: Study
12/06/2022
 
 
TXT Team Biologics Needs More Staff, Training: Former FDAers
12/06/2022
 
 
TXT Pass VALID Act Now: Former Commissioners
12/06/2022
 
 
TXT Guide on PK-Based Criteria for PD1/PD-L1 Alt Dosing
12/06/2022
 
 
TXT Contract Lab Valisure Relinquishes its Testing Prowess
12/06/2022
 
 
TXT FDA Updates Endologix Endovascular Graft Safety
12/06/2022
 
 
TXT Firms Seek EUA for Omicron Vaccine in Young Children
12/05/2022
 
 
TXT Novartis Seeking Expanded Pluvicto Use
12/05/2022
 
 
TXT Guide on ‘Selective’ Drug Safety Data Collection
12/05/2022
 
 
TXT Clinical Hold Issues Outlined for Cholesterol Gene Therapy
12/05/2022
 
 
TXT FDA Confirms Survival Rate With Abiomed’s Heart Device
12/05/2022
 
 
TXT Getinge Intra-Aortic Balloon Pumps on Shortage Lis
12/02/2022
 
 
TXT Draft Guide on Bioequivalence Statistical Approaches
12/02/2022
 
 
TXT Oncologic Drugs Committee Renewed for 2 Years
12/02/2022
 
 
TXT Biden Signs Medical Marijuana/Cannabidiol Research Law
12/02/2022
 
 
TXT Medtronic HeartWare ‘Dear Doctor’ Letter
12/01/2022
 
 
TXT Lilly’s Donanemab Tops Aduhelm in Study
12/01/2022
 
 
TXT Act on Orphan Drug Exclusivity: Attorney
12/01/2022
 
 
TXT Medical Device Recalls at Two-Year High: Sedgwick
12/01/2022
 
 
TXT Make UDI Publicly Available in Databases: Petition
12/01/2022
 
 
TXT FDA Grants, Denies Parts of Microbiome Petition
11/30/2022
 
 
TXT 2 Admit Role in $38 Million Compounding Fraud
11/30/2022
 
 
TXT Congress Should Pass VALID Act on LDTs: Advocates
11/30/2022
 
 
TXT Janssen Sues Amgen Over Stelara Biosimilar Plans
11/30/2022
 
 
TXT Merck in Keytruda Patent Dispute with Johns Hopkins
11/30/2022
 
 
TXT Lilly’s Bebtelovimab Not Authorized in U.S.
11/30/2022
 
 
TXT Eisai/Biogen Report ‘Promising’ Alzheimer’s Data
11/30/2022
 
 
TXT Ex-BD Official Seeks DoJ Referral Against Company
11/29/2022
 
 
TXT ‘Objectionable Conditions’ at Arbor Eyecare
11/29/2022
 
 
TXT CDER Hearing Delay on NDA is ‘Unfounded’: Lexicon
11/29/2022
 
 
TXT Suggestions to Improve OTC Drug Draft Reg
11/29/2022
 
 
TXT Roche Withdraws Tecentriq Bladder Cancer Indication
11/29/2022
 
 
TXT ‘Skinny Labels’ Lead to Earlier Competition: Study
11/29/2022
 
 
TXT Supplement Reform Appears Dead for 2022: Report
11/29/2022
 
 
TXT Caribou Bio Wins 2 Designations from FDA
11/29/2022
 
 
TXT FDA Rejects Spectrum's Lung Cancer Drug
11/28/2022
 
 
TXT Sarepta BLA for Duchenne Muscular Dystrophy
11/28/2022
 
 
TXT NeuroLogica BodyTom CT Scanner Cleared by FDA
11/28/2022
 
 
TXT Enforcement Guide on Fecal Microbiota for Transplantation
11/28/2022
 
 
TXT No REMS Needed for Gene Therapy: FDA
11/28/2022
 
 
TXT Device Color Additive Risk Calculator Qualified
11/28/2022
 
 
TXT 2nd Alzheimer’s Therapy Death Raises Questions: Journal
11/28/2022
 
 
TXT Luer-Activated Valve Connector FDA Alert
11/23/2022
 
 
TXT Janssen Says Spravato Tops Seroquel in Trial
11/23/2022
 
 
TXT EUA for Lucira Covid-19 and Flu Test
11/23/2022
 
 
TXT FDA Waives Panel Meeting on Biomarin Gene Therapy
11/23/2022
 
 
TXT Controversy Seen in CDS Software Final Guidance
11/22/2022
 
 
TXT Alert on Prolia and Severe Hypocalcemia
11/22/2022
 
 
TXT FDA Modeling, Simulation Successes
11/22/2022
 
 
TXT GSK Pulls Blenrep Accelerated Approval at FDA’s Request
11/22/2022
 
 
TXT New Hemophilia B Gene Therapy Approved
11/22/2022
 
 
TXT Multiple Violations at Invitrx Therapeutics
11/22/2022
 
 
TXT Latest Philips Respironics MDRs
11/22/2022
 
 
TXT Webinar on Rx Drug Labeling Resources
11/21/2022
 
 
TXT FDA Updates Web Page on Medtronic HeartWare Recalls
11/21/2022
 
 
TXT Zimmer Biomet New Persoa Tibis Cleared
11/21/2022
 
 
TXT FDA OKs Jazz sBLA for Mon./Wed./Fri. Rylaze Dosing
11/21/2022
 
 
TXT Gamida Cell BLA Review Extended by 3 Months
11/21/2022
 
 
TXT Provention Bio Diabetes Delayer Approved
11/18/2022
 
 
TXT Inspections Focusing on Management Responsibility: FDA
11/18/2022
 
 
TXT Pfizer/BioNTech on ‘Encouraging’ Covid Booster Data
11/18/2022
 
 
TXT Iovance Pushes Back BLA for Melanoma Therapy
11/18/2022
 
 
TXT Bernie Sanders to Head HELP Committee
11/18/2022
 
 
TXT Philips Respironics Reports More Problems with Ventilators
11/18/2022
 
 
TXT FDA Cybersecurity Modernization Action Plan
11/17/2022
 
 
TXT Comments Sought on Proposed NDC Revision
11/17/2022
 
 
TXT FDA Warns 7 Supplement Companies About CV Claims
11/17/2022
 
 
TXT FDA Approves Lilly Interchangeable Insulin Product
11/17/2022
 
 
TXT 9 Senators Want FDA Medication Abortion Action
11/17/2022
 
 
TXT Advisors Back Ardelyx’ Kidney Disease Drug
11/17/2022
 
 
TXT Pazdur Puts Foot Down on Single Country Trials
11/17/2022
 
 
TXT FDA Planning White Oak Return Under Hybrid Approach
11/17/2022
 
 
TXT Class 1 Recall on Omnipod Insulin Delivery System
11/17/2022
 
 
TXT FDA Denies 2 Covid-19 Vaccine Petitions
11/16/2022
 
 
TXT Takeaways from Clinical Trial Enforcement Panel
11/16/2022
 
 
TXT NEST Unique Device Identifier Playbook
11/16/2022
 
 
TXT Pass PASTEUR Act Before Congress Ends: 165 Groups
11/16/2022
 
 
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The most authoritative FDA news analysis each week is found in the pages of Dickinson's FDA Review. Since 1984, this newsletter has been providing in-depth reports on the most significant FDA developments affecting the pharmaceutical, medical device, biologics and veterinary medicines industries. Unlike other media, FDA Review eliminates time-wasting minutia and presents in clear, concise language the essence of what's really important - and why. It is the publication that FDA officials themselves read. Delivered in the middle of each week, FDA Review presents:
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